Consultant Clinical Affairs

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Dortmund, North Rhine-Westphalia, Germany

Full‑time, Mid‑Senior level, Consulting, Business Consulting and Services

• Plan deliverables, deadlines and ensure those are well‑communicated and performed on time.
• Recommend the best strategy to be used for the clinical evaluation considering regulatory requirements, device claims and available clinical data.
• Set clinical outcome parameters and acceptance criteria to support the clinical claims of the devices.
• Perform design and appraisal of systematic literature searches on multiple databases (Pub Med, Science Direct, Clinical Trials and others), including adverse event ones, such as MAUDE, FDA Medical Device Recalls and similar.
• Elaborate, update and peer review Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Literature Search Reports (LSRs).
• Write state of the art (SOTA) text based on selected data.
• Ensure that peer review of any documentation is performed internally prior to delivery to the client.
• Answer questions from Regulatory Authorities regarding clinical evaluation.
• Provide strategic advice in relation to all aspects of compliance, including the relationship with and/or participation in interactions with Notified Bodies, Certification Bodies and/or National Authorities.
• Ensure customer satisfaction, adherence to Qserve and customer policies and procedures in the conduct of work.

• Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, biomedical science, biology, or similar.
• At least 4 years of experience in clinical evaluation of medical devices (EU‑MDD and EU‑MDR) in industry, consultancy, or Notified Body roles.
• Hands‑on experience with systematic literature search design and appraisal of medical devices.
• Familiarity with ISO 13485 and medical device Quality Management Systems.
• Experience on post‑market clinical follow‑up (PMCF) and Summary of Safety and Clinical Performance (SSCP) are considered advantages.
• Pragmatic approach and ability to manage multiple projects simultaneously.
• Excellent communication skills in English.